Press Release

POZEN Receives Initial FDA Response To PA32540 SPA

CHAPEL HILL, N.C., Aug 01, 2008 (BUSINESS WIRE) -- POZEN Inc. (NASDAQ: POZN), today announced that the U.S. Food and
Drug Administration (FDA) has provided an initial response to POZEN's
Special Protocol Assessment (SPA) for PA32540, which was submitted in
June 2008. The company plans to meet with the FDA to discuss their
responses to our proposed protocol for the Phase 3 pivotal studies,
including the inclusion/exclusion criteria, the stratification plan,
the primary endpoint, and the statistical methodology to be used in
the study. The company also plans to discuss an additional
pharmacodynamic study requested by the FDA which would support the
bioequivalence study previously conducted for PA32540.

The SPA is a process by which the FDA and the company reach an
agreement on the Phase 3 pivotal trial protocol design, clinical
endpoints, and statistical analyses that are acceptable to support
regulatory approval. An SPA is binding upon the FDA and the Sponsor
unless a substantial scientific issue essential to determining safety
or efficacy is identified after the testing is begun. For more
information please visit the FDA website:
www.fda.gov/CbER/gdlns/protocol.pdf.

About POZEN

POZEN is a pharmaceutical company committed to developing
therapeutic advancements for diseases with unmet medical needs where
it can improve efficacy, safety, and/or patient convenience. POZEN's
efforts are focused primarily on the development of pharmaceutical
products for the treatment of acute and chronic pain and other
pain-related conditions. POZEN has development and commercialization
alliances with GlaxoSmithKline for Treximet(TM), which was recently
approved by the United States Food and Drug Administration for the
acute treatment of migraine attacks, with or without aura, in adults,
and with AstraZeneca for proprietary fixed dose combinations of
naproxen with the proton pump inhibitor esomeprazole magnesium in a
single tablet for conditions such as osteoarthritis and rheumatoid
arthritis in patients who are at risk for developing NSAID-associated
gastric ulcers. The company's common stock is traded on The Nasdaq
Stock Market under the symbol "POZN". For detailed company
information, including copies of this and other press releases, see
POZEN's website: www.pozen.com.

Statements included in this press release that are not historical
in nature are "forward-looking statements" within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are subject
to a number of risks and uncertainties, including, but not limited to,
our failure to successfully commercialize our product candidates;
costs and delays in the development and/or FDA approval of our product
candidates, including as a result of the need to conduct additional
studies, or the failure to obtain such approval of our product
candidates, including as a result of changes in regulatory standards
or the regulatory environment during the development period of any of
our product candidates; uncertainties in clinical trial results or the
timing of such trials, resulting in, among other things, an extension
in the period over which we recognize deferred revenue or our failure
to achieve milestones that would have provided us with revenue; our
inability to maintain or enter into, and the risks resulting from our
dependence upon, collaboration or contractual arrangements necessary
for the development, manufacture, commercialization, marketing, sales
and distribution of any products, including our dependence on
GlaxoSmithKline for the sales and marketing of Treximet; competitive
factors; our inability to protect our patents or proprietary rights
and obtain necessary rights to third party patents and intellectual
property to operate our business; our inability to operate our
business without infringing the patents and proprietary rights of
others; general economic conditions; the failure of any products to
gain market acceptance; our inability to obtain any additional
required financing; technological changes; government regulation;
changes in industry practice; and one-time events, including those
discussed herein and in our Quarterly Report on Form 10-Q for the
period ended June 30, 2008. We do not intend to update any of these
factors or to publicly announce the results of any revisions to these
forward-looking statements.